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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT

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CAREFUSION/BD RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Catalog Number 2K8032
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2017
Event Type  Injury  
Manufacturer Narrative
Follow up submission: one opened sample was received for evaluation. A leak test, inhalation test and exhalation test was performed and we were unable to confirm the leak reported by the customer. In addition, a visual inspection was performed and it was found that the component with p/n 65-4377d (pop off housing) was broken, this broken condition does not affect the functionality of the product. A dhr was completed and no issues were found relating to the leak condition reported or the broken condition that was found during visual inspection. Based on the investigation we were not able to confirm the leak on the sample returned by the customer. The sample passed all functional tests. At this time no corrective actions are indicated. However, manufacturing personnel have been made aware of this issue.
 
Manufacturer Narrative
Customer advocacy has reached out to customer to provide sample for the investigation. Ups label was provided to the customer. At this time we are currently waiting for the sample. Once the investigation is complete or if we receive any additional information we will provide a follow up emdr. (b)(4).
 
Event Description
Customer reported that the "bag does not inflate". Reported item was being used on patient. No patient harm or medical intervention was required. Customer report "that the patient did not have a low oxygen saturation the device was replaced immediately upon noticing the issue".
 
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Brand NameRESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
CAREFUSION/BD
cerrada vía de la producción
no. 85 parque industrial
mexicali baja california norte
MX
Manufacturer (Section G)
CAREFUSION/BD
cerrada vía de la producción
no.85 parque industrial
mexicali baja california norte
MX
Manufacturer Contact
mindy faber
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6533004
MDR Text Key208511711
Report Number8030673-2017-00329
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8032
Device Lot Number0000710419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/29/2017 Patient Sequence Number: 1
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